Device brand name · Skin graft products
Padgett Model S Slimline Electric Dermatome: medical device reports filed with FDA
247 reports name it, 2006–2024. Manufacturer given most often on reports: Integra Lifesciences Oh/USA. Product code GFD.
- 247
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 75.7%
- classified as malfunction
- 79.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 247 reports that name the brand "Padgett Model S Slimline Electric Dermatome" (skin graft products), received between June 2006 and August 2024; the manufacturer given most often on reports is Integra Lifesciences Oh/USA. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (75.7%), injury (20.6%) and other (3.2%); across all dermatome reports (product code GFD) death is recorded in 0% and malfunction in 79.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (34.4%), failure to cut (9.3%) and calibration problem (7.3%). The patient problems coded most often are no patient involvement, tissue damage and injury. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,195 reports carrying product code GFD. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 85 | 34.4% | 14% |
| Failure to cut | 23 | 9.3% | 26.9% |
| Calibration problem | 18 | 7.3% | 3.1% |
| Device stops intermittentlythe device stopped now and then | 17 | 6.9% | 0.7% |
| Device inoperablethe device could not be used | 16 | 6.5% | 2% |
| Loss of powerthe device lost power | 10 | 4% | 1.8% |
| Breakthe device broke | 9 | 3.6% | 2.2% |
| Failure to calibrate | 7 | 2.8% | 0.2% |
| Failure to power up | 6 | 2.4% | 2.4% |
| Mechanics altered | 6 | 2.4% | 0.4% |
| Power problem | 5 | 2% | 6.2% |
| Loose or intermittent connection | 4 | 1.6% | 1.5% |
| Noise, audible | 4 | 1.6% | 2.7% |
| Sticking | 4 | 1.6% | 0.6% |
| Insufficient device problem information | 3 | 1.2% | 1.7% |
| Mechanical problema mechanical problem | 3 | 1.2% | 3.1% |
| Application interface becomes non-functional or program exits abnormally | 2 | 0.8% | 0.1% |
| Device contamination with chemical or other material | 2 | 0.8% | 0% |
| Device slipped | 2 | 0.8% | 0.3% |
| Fitting problem | 2 | 0.8% | 1.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 39 | 15.8% |
| Tissue damage | 26 | 10.5% |
| Injurya physical injury | 10 | 4% |
| Laceration(s) | 4 | 1.6% |
| Skin tears | 3 | 1.2% |
| Scarring | 2 | 0.8% |
| Abrasion | 1 | 0.4% |
| Fluid discharge | 1 | 0.4% |
| Impaired healingslow healing | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Padgett Model S Slimline Electric Dermatome | Product code GFD | All MAUDE reports |
|---|---|---|---|
| Reports | 247 | 8,195 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 20.6% | 19.5% | 36.2% |
| Classified as malfunction | 75.7% | 79.4% | 62.3% |
| Filed by the manufacturer | 100% | 96.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code GFD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Zimmer Air Dermatome | 2,687 | 372 | 0% |
| Handpiece Electric Dermatome | 1,825 | 174 | 0% |
| Air Dermatome Handpiece | 511 | 0 | 0% |
| Dermatome AN Handpiece | 446 | 117 | 0% |
| Electric Dermatome Handpiece | 265 | 0 | 0% |
| Air Dermatome Kit | 205 | 0 | 0% |
| Dermatome Blades | 170 | 5 | 0% |
| Zimmer Skin Graft Mesher | 3,463 | 285 | 0% |
| Zimmer | 1,159 | 0 | 2.8% |
| Fan Spray Kit | 850 | 173 | 0% |
| Hip Kit | 652 | 135 | 0% |
| Universal Hose 10 | 153 | 0 | 0% |
| Z S G M Cutter 1 5 1 Ratio Caution Sharp | 342 | 17 | 0% |
| Z S G M Cutter 2 1 Ratio Caution Sharp | 220 | 6 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Padgett Model S Slimline Electric Dermatome reports
How many FDA reports name Padgett Model S Slimline Electric Dermatome?
247 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (75.7%), injury (20.6%) and other (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (34.4%), failure to cut (9.3%), calibration problem (7.3%), device stops intermittently (6.9%) and device inoperable (6.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Padgett Model S Slimline Electric Dermatome was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.