MedDRA preferred term · the device leaked

Device leakage: adverse event reports recording this term

41,778 reports to FDA record it, 2005–2026; 0.2% of the database.

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: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

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.

41,778
reports recording the term: 0.2% of all reports; 5,807
reports, 12 months to June 2026: 6,496 in the 12 months before; 12.8%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

"Device leakage" (in plain words, the device leaked) is a MedDRA preferred term recorded in 41,778 adverse event reports received by FDA, 0.2% of the database, from July 2005 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

5,807 reports recorded it in the 12 months to June 2026, down 11% from 6,496 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 12.8% are marked serious, 0.6% include death among the outcomes and 6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Genotropin, Eligard and Bydureon Bcise. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Genotropin	—	8,991	20%
Eligard	Gonadotropin releasing hormone receptor agonist	6,086	13.7%
Bydureon Bcise	—	4,594	35.7%
Bydureon	—	1,376	7.1%
Neulasta	Leukocyte growth factor	1,344	1.7%
Omnitrope	Recombinant human growth hormone	1,230	10.9%
Cosentyx	Interleukin-17A antagonist	1,224	0.8%
Tanzeum	—	1,195	14.2%
Device	—	1,125	22.2%
Risperdal Consta	—	946	7%
Remodulin	Prostacycline vasodilator	832	1.7%
Tremfya	Interleukin-23 antagonist	798	2.5%
Wegovy	GLP-1 receptor agonist	793	4.1%
Orencia	Selective T cell costimulation modulator	613	0.6%
Ajovy	—	564	5.6%
Simponi	Tumor necrosis factor blocker	560	0.8%
Humira	—	466	0.1%
Fasenra	Interleukin-5 receptor alpha-directed cytolytic antibody	403	2.8%
Nemluvio	—	336	2.8%
Enbrel	Tumor necrosis factor blocker	326	0.1%
Somatropin	Recombinant human growth hormone	317	5.7%
Veletri	Prostacycline vasodilator	309	3.5%
Duopa	Aromatic amino acid	265	3.1%
Carbidopa levodopa	Aromatic amino acid	263	1.3%
Medroxyprogesterone	Progestin	250	8.3%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.2% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Gonadotropin releasing hormone receptor agonist	6,216	10.1%	0%
Recombinant human growth hormone	1,580	7.4%	2.2%
Leukocyte growth factor	1,423	1.3%	0%
GLP-1 receptor agonist	1,295	0.3%	0.1%
Prostacycline vasodilator	1,262	1.1%	0.2%
Interleukin-17A antagonist	1,241	0.7%	0.1%
Tumor necrosis factor blocker	1,061	0.1%	0%
Interleukin-23 antagonist	1,020	0.9%	0.1%
Selective T cell costimulation modulator	698	0.5%	0.5%
Progestin	556	0.2%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.6%231

2 to 118.4%3,518

12 to 179%3,748

18 to 447.8%3,262

45 to 6415.7%6,542

65 to 7410.9%4,570

75 and over8.2%3,430

Age not given39.4%16,477

Patient sex

Female41.4%17,286

Male44.5%18,584

Not given14.1%5,908

Grey bar: all 20,646,523 reports in the database. 79.2% of these reports give the United States as the country.

Questions about "Device leakage"

What does "Device leakage" mean in an adverse event report?

In plain language: the device leaked. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record device leakage?

41,778 reports through June 2026 (0.2% of all reports), 5,807 of them in the latest 12 months.

Which drugs appear most often in these reports?

Genotropin (8,991), Eligard (6,086), Bydureon Bcise (4,594), Bydureon (1,376) and Neulasta (1,344). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.