MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-06 for ETHICON * manufactured by Ethicon Inc.
[20196162]
S/p laparoscopic supra cervical hysterectomy with left paratubal cystectomy pt found to have what appeared to be "burns" at the traochar insertion sites. Wound closed by plastic surgeon without difficulty and formed the skin condition "trauma" and "excoriation. " no equipment malfunction found by medical engineering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037663 |
| MDR Report Key | 663194 |
| Date Received | 2006-01-06 |
| Date of Report | 2005-12-20 |
| Date of Event | 2005-12-01 |
| Date Added to Maude | 2006-01-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON |
| Generic Name | MIRCELATOR |
| Product Code | HFG |
| Date Received | 2006-01-06 |
| Returned To Mfg | 2005-12-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 652621 |
| Manufacturer | ETHICON INC |
| Manufacturer Address | RT 22 WEST BOX 151 SUMMERVILLE NY *0151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-06 |