Gentrix® PSMX0710 (UDI 00386190001851)Recalls & reported problems
Acell, Inc. · Gentrix® Surgical Matrix, 7cm x 10cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001851), received between Feb 7, 2020 and Feb 7, 2020 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2020, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THE PATIENT EXPERIENCED A HERNIA RECURRENCE. THE DEVICE IMPLANTATION SURGERY WAS A REDO LAPAROSCOPIC HIATAL HERNIA REPAIR WITH NISSEN FUNDOPLICATIONON ON (B)(6) 2020. THE PATIENT EXPERIENCED A SECOND HERNIA RECURRENCE AND WAS REOPERATED ON (B)(6) 2020, WHEN SOME OF THE DEVICE WAS PARTIALLY EXPLANTED BUT THE DEVICE WAS OTHERWISE MAINTAINED SUPERIORLY AND MEDIALLY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9683892 ↗
Other Mesh, surgical, collagen, diaphragmatic hernia devices
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- Peri-Guard PG1225Synovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Supple Peri-Guard PC0608SNSynovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG1016Synovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Supple Peri-Guard PC1016SNSynovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG0404Synovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- XENMATRIX 1161015Davol Inc. · Mesh, surgical, collagen, diaphragmatic hernia13 reports
- XENMATRIX 1161928Davol Inc. · Mesh, surgical, collagen, diaphragmatic hernia9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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