MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-11-27 for PAVLIK HARNESS * 1716 manufactured by Zimmer Orthopaedic Surgical Products.
[17482597]
A pt wearing the pavlik harness came for a routine check. When removing the harness, it was noted that a string from the front velcro strap had caught on their calf and had allegedly caused a laceration. The wound required steristrips and a course of antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2002-00004 |
| MDR Report Key | 430667 |
| Report Source | 05,06 |
| Date Received | 2002-11-27 |
| Date of Report | 2002-11-04 |
| Date Facility Aware | 2002-11-01 |
| Report Date | 2002-11-04 |
| Date Reported to Mfgr | 2002-11-01 |
| Date Mfgr Received | 2002-11-01 |
| Date Added to Maude | 2002-12-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA OSORIO |
| Manufacturer Street | 200 W. OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAVLIK HARNESS |
| Generic Name | HIP ABDUCTION DEVICE |
| Product Code | IOZ |
| Date Received | 2002-11-27 |
| Model Number | * |
| Catalog Number | 1716 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 419648 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 200 W OHIO AVE. DOVER OH 44622 US |
| Baseline Brand Name | PAVLIK HARNESS |
| Baseline Generic Name | HIP ABDUCTION DEVICE |
| Baseline Model No | * |
| Baseline Catalog No | 1716 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-11-27 |