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 |