MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-12-06 for MAGRINA BOOKWALTER VAGINAL RETRACTOR manufactured by Johnson & Johnson Professional, Inc.
[16264710]
Customer reports that there was a vaginal tear at 4 o'clock that occurred after removing retractor. Approx 1 1/2" repaired. No further bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1999-00196 |
| MDR Report Key | 253123 |
| Report Source | 05,06 |
| Date Received | 1999-12-06 |
| Date of Report | 1999-12-06 |
| Date of Event | 1999-11-10 |
| Date Mfgr Received | 1999-11-11 |
| Date Added to Maude | 1999-12-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGRINA BOOKWALTER VAGINAL RETRACTOR |
| Generic Name | RETRACTOR, VAGINAL |
| Product Code | HDL |
| Date Received | 1999-12-06 |
| Model Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 245089 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC |
| Baseline Brand Name | MAGRINA BOOKWALTER VAGINAL RETRACTOR |
| Baseline Generic Name | RETRACTOR, VAGINAL |
| Baseline Model No | NA |
| Baseline Catalog No | 50-4591 |
| Baseline ID | NA |
| Baseline Device Family | MAGRINA BOOKWALTER VAGINAL RETRACTOR |
| Baseline Shelf Life [Months] | NA |
| 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. Other | 1999-12-06 |