MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-03-06 for PAVILIK HARNESS * 00-1716-011-00 manufactured by Zimmer Ortho Surgical Products.
[273170]
The harness was fitted to an infant, the child seemed to be in some discomfort and would not stop crying. On examination of the harness the point of an industrial sewing needles was allegedly discovered embedded in the lining.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2002-00002 |
| MDR Report Key | 381121 |
| Report Source | 05,06 |
| Date Received | 2002-03-06 |
| Date of Report | 2002-03-04 |
| Date Facility Aware | 2002-02-04 |
| Report Date | 2002-03-04 |
| Date Reported to Mfgr | 2002-02-04 |
| Date Mfgr Received | 2002-02-04 |
| Date Added to Maude | 2002-03-14 |
| 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 |
| Manufacturer Contact | PAULA OSORIO |
| Manufacturer Street | 200 W. OHIO AVENUE |
| 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 | PAVILIK HARNESS |
| Generic Name | HIP ABDUCTION SPLINT |
| Product Code | IOZ |
| Date Received | 2002-03-06 |
| Model Number | * |
| Catalog Number | 00-1716-011-00 |
| Lot Number | 60110011 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 370171 |
| Manufacturer | ZIMMER ORTHO SURGICAL PRODUCTS |
| Manufacturer Address | 200 W. OHIO AVENUE DOVER OH 44622 US |
| Baseline Brand Name | PAVLIK HARNESS |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | 00-1716-011-00 |
| Baseline ID | HIP ABDUCTION S |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-03-06 |