MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for SNYDER HEMOVAC DRAIN SMALL 259-000-10 manufactured by Zimmer Patient Care Division.
[20989935]
Patient underwent posterior transverse process fusion segmental pedide stabilization and iliac bone graft on 3/31/93. Four hemovak drains were removed on 4/1/93. One of these four drains broke off necessitating a surgery on 4/3/93 for its removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10091 |
| MDR Report Key | 10091 |
| Date Received | 1993-08-31 |
| Date of Report | 1993-07-28 |
| Date of Event | 1993-04-01 |
| Date Facility Aware | 1993-04-01 |
| Report Date | 1993-07-28 |
| Date Reported to FDA | 1993-07-28 |
| Date Reported to Mfgr | 1993-04-01 |
| Date Added to Maude | 1993-09-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNYDER HEMOVAC DRAIN |
| Product Code | BYH |
| Date Received | 1993-08-31 |
| Model Number | SMALL |
| Catalog Number | 259-000-10 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 10091 |
| Manufacturer | ZIMMER PATIENT CARE DIVISION |
| Manufacturer Address | DOVER OH 446720010 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-31 |