MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-12-12 for WECK * UNK manufactured by Pilling Weck.
[38449]
Physician used delivery forceps to assist with delivery of infant. After examination of newborn it was noticed that a laceration to rt eye lid was sustained. The forceps appear to be smooth and free of any defects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-1996-00003 |
| MDR Report Key | 56150 |
| Report Source | 05 |
| Date Received | 1996-12-12 |
| Date of Report | 1996-08-23 |
| Date of Event | 1996-08-20 |
| Date Facility Aware | 1996-08-20 |
| Report Date | 1996-08-23 |
| Date Reported to Mfgr | 1996-08-29 |
| Date Mfgr Received | 1996-09-03 |
| Device Manufacturer Date | 1974-01-01 |
| Date Added to Maude | 1996-12-18 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WECK |
| Generic Name | SIMPSONS SM # 30 FORCEPS |
| Product Code | HCZ |
| Date Received | 1996-12-12 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | 74 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 56674 |
| Manufacturer | PILLING WECK |
| Manufacturer Address | ONE WECK DRIVE RESEARCH TRIANGLE PARK NC 27709 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-12 |