MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-21 for MEPITEL NOT KNOWN 290799 manufactured by Molnlycke Health Care.
[1752562]
Clinician stated (3) 3"x4" pieces of mepitel were placed onto a female patient's bowel underneath a kci wound vac (2 vertical and 1 horizontal). The patient had no fascia on the bowel, according to the clinician. The v. A. C. Had only been on for 3 hours and the patient started to eviscerate underneath the v. A. C. They removed the v. A. C. And then pulled off the pieces of mepitel. Two pieces of mepitel was sticking onto the bowel. They used saline solution to try to get the stuck piece of mepitel off the bowel. When that did not work, they had to remove 3rd one in operating room. In the operating room, they had perforated a hole in the bowel about 1 cm x 1 cm while trying to get the mepitel off the bowel. Operating room had patched the hole on bowel. The clinician was contacted to check on the patient, she stated the patient is doing much better since the incident.
Patient Sequence No: 1, Text Type: D, B5
[8744071]
No review of the device history record could be conducted as no lot number or sample was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004763499-2010-00004 |
| MDR Report Key | 1884097 |
| Report Source | 05 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-09-22 |
| Date Mfgr Received | 2010-09-22 |
| Date Added to Maude | 2010-10-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRACEY MURRAY, ASSOCIATE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 6782507912 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEPITEL |
| Generic Name | MEPITEL |
| Product Code | MGP |
| Date Received | 2010-10-21 |
| Model Number | NOT KNOWN |
| Catalog Number | 290799 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTH CARE |
| Manufacturer Address | NORCROSS GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-21 |