MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for GYN PACK (GYCTF) 839 SMA73GYCT2 manufactured by Cardinal Health 200 Llc.
[140771671]
Ob gyn pack with incorrect number of raytec sponges. Contents form states should have 10 sponges and there were only 9.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085440 |
| MDR Report Key | 8470888 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-07 |
| Date Added to Maude | 2019-04-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GYN PACK (GYCTF) 839 |
| Generic Name | GYNECOLOGICAL LAP KIT |
| Product Code | OHD |
| Date Received | 2019-03-29 |
| Catalog Number | SMA73GYCT2 |
| Lot Number | 978768 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |