MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-16 for MEDICAL ACTION (ACQUIRED BY OWENS & MINOR) LAP SPONGES 4304000400 manufactured by Owens & Minor.
[19608472]
Six phs total knee packs were opened (lot# 1178757), catalog#: 622258). All or packs had contaminants. Four contaminants were in the lap sponges; 1 dust in pack: 1 stockinet issue. The lap sponges found in the phs packs are made by medical action. Vendor item#: (b)(4). Description: sponge, lap 18x18 pre-washed. Warehousing: (b)(4). One medical action lap sponge lot (lot#pl1411f01) was known to be seriously contaminated with particulates. It is unk if the lap sponges in these 4 lap packs were lot #pl1411f01, as the focus at the time was on the phs pack itself. Focusing on medical action for the lap sponges in packs: (b)(4). Phs packs =(b)(4). Same reporter in mw5043161- mw5043178.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043162 |
| MDR Report Key | 4859389 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-05-08 |
| Date Added to Maude | 2015-06-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL ACTION (ACQUIRED BY OWENS & MINOR) LAP SPONGES |
| Generic Name | LAP SPONGE (INSIDE PACK) |
| Product Code | GDY |
| Date Received | 2015-06-16 |
| Catalog Number | 4304000400 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 9210 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Brand Name | MEDICAL ACTION (ACQUIRED BY OWENS & MINOR) LAP SPONGES |
| Generic Name | LAP SPONGE (INSIDE PACK) |
| Product Code | GDY |
| Date Received | 2015-06-16 |
| Catalog Number | 4304000400 |
| Lot Number | UNK |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | OWEN & MINOR |
| Manufacturer Address | 9210 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Brand Name | MEDICAL ACTION (ACQUIRED BY OWENS & MINOR) LAP SPONGES |
| Generic Name | LAP SPONGE (INSIDE PACK) |
| Product Code | GDY |
| Date Received | 2015-06-16 |
| Catalog Number | 4304000400 |
| Lot Number | UNK |
| Device Availability | N |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 9210 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Brand Name | MEDICAL ACTION (ACQUIRED BY OWENS & MINOR) LAP SPONGES |
| Generic Name | LAP SPONGE (INSIDE PACK) |
| Product Code | GDY |
| Date Received | 2015-06-16 |
| Catalog Number | 4304000400 |
| Lot Number | UNK |
| Device Availability | N |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 9210 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Brand Name | PHS TOTAL KNEE PACK |
| Generic Name | PACK |
| Product Code | KKX |
| Date Received | 2015-06-16 |
| Catalog Number | 622258 |
| Lot Number | 1178757 |
| Device Availability | N |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Brand Name | NI |
| Generic Name | STOCKINET |
| Product Code | ITG |
| Date Received | 2015-06-16 |
| Device Availability | N |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-16 |