Device brand name · Ear piercing instrument and ear piercing earrings

Inverness Ear Piercing System: medical device reports filed with FDA

387 reports name it, 1997–2007. Manufacturer given most often on reports: Inverness. Product code JYS.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

387
device reports naming the brand: 0% of all MAUDE reports · about 13 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0%
classified as malfunction: 0% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 387 reports that name the brand "Inverness Ear Piercing System" (ear piercing instrument and ear piercing earrings), received between August 1997 and November 2007; the manufacturer given most often on reports is Inverness. 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 other (99.2%) and injury (0.5%); across all perforator, ear-lobe reports (product code JYS) death is recorded in 0% and malfunction in 0%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are reaction (9.8%), device, removal of (non-implant) (7%) and other (for use when an appropriate device code cannot be identified) (4.9%). The patient problems coded most often are treatment with medication(s), therapy/non-surgical treatment, additional and swelling. 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

No report naming Inverness Ear Piercing System was received in the five years to August 2026; the latest was received in November 2007.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.5%2

Malfunction0%0

Other99.2%384

Not given0.3%1

Who filed the report

Manufacturer report100%387

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 393 reports carrying product code JYS. 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
Reactiona reaction, type not specified	38	9.8%	10.2%
Device, removal of (non-implant)	27	7%	7.4%
Other (for use when an appropriate device code cannot be identified)	19	4.9%	4.8%
Entrapment of device	15	3.9%	3.8%
Sticking	4	1%	0.8%
Difficult to removethe device was hard to remove	3	0.8%	0.5%
Migration or expulsion of device	1	0.3%	0.3%

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
Treatment with medication(s)	283	73.1%
Therapy/non-surgical treatment, additional	150	38.8%
Swellingswelling	105	27.1%
Surgical procedure	79	20.4%
Hospitalization required	71	18.3%
Erythemaskin redness	59	15.2%
Painpain, site not specified	30	7.8%
Surgical procedure, additional	16	4.1%
Foreign body, removal of	15	3.9%
Other (for use when an appropriate patient code cannot be identified)	9	2.3%
Abscessa collection of pus	8	2.1%
Drainage	8	2.1%
Bacterial infectiona bacterial infection	5	1.3%
Inflammationinflammation	5	1.3%
Discharge	4	1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Inverness Ear Piercing System	Product code JYS	All MAUDE reports
Reports	387	393	26,136,888
Share of that pool	—	98.5%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0.5%	0.5%	36.2%
Classified as malfunction	0%	0%	62.3%
Filed by the manufacturer	100%	99.7%	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."

Questions about Inverness Ear Piercing System reports

How many FDA reports name Inverness Ear Piercing System?

387 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?

other (99.2%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

reaction (9.8%), device, removal of (non-implant) (7%), other (for use when an appropriate device code cannot be identified) (4.9%), entrapment of device (3.9%) and sticking (1%). 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 Inverness Ear Piercing System 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.