MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-11 for PENROSE DRAIN UNKNOWN manufactured by Davol.
[15007180]
Penrose drains removed. One side came out in pieces; patient had surgery to remove penrose pieces. Device labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: material degradation/deterioration. Conclusion: device failure directly caused event, device unavailable for follow-up investigation examination. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5105 |
| MDR Report Key | 5105 |
| Date Received | 1993-06-11 |
| Date of Report | 1993-05-17 |
| Date of Event | 1993-04-12 |
| Date Facility Aware | 1993-04-12 |
| Report Date | 1993-05-17 |
| Date Reported to Mfgr | 1993-05-17 |
| Date Added to Maude | 1993-06-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENROSE DRAIN |
| Generic Name | PENROSE DRAIN |
| Product Code | HFL |
| Date Received | 1993-06-11 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | REORDER #91801 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 4808 |
| Manufacturer | DAVOL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-06-11 |