MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-26 for ACCUMESH AMPMED manufactured by Covidien Lp Llc North Haven.
[87515163]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[87515164]
According to the reporter, the patient underwent a laparoscopic incisional hernia repair for a lateral to midline hernia. While positioning the mesh, the 15 cm circle mesh was attached correctly to the device. The mesh was rolled according to instruction into the mesh introducer sleeve. The introducer sleeve was inserted into the trocar. The surgeon continued to rotate the mesh as it was pushed forward into the abdominal cavity. Upon entry into the abdominal cavity, it was noted that the mesh twisted around the accumesh frame and snagged on the frame in a manner that would prevent the frame from opening. The mesh had to be torn off of the frame in order to remove it from the patient. A new device and mesh was opened to finish the procedure. Suture was done for wound closure. Reliatack fixation was used with many fixation points with a 12 mm trocar. Patient was alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-07391 |
| MDR Report Key | 6893300 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-26 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUMESH |
| Product Code | ORQ |
| Date Received | 2017-09-26 |
| Model Number | AMPMED |
| Catalog Number | AMPMED |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-26 |