MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-12 for LAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH AC851 IRU-516-856 manufactured by Teleflex - Rusch.
[2102458]
Surgeon placed lawrence suprapubic catheter introducer, but was unable to thread a catheter. A piece broke of the outer sheath of the introducer causing the outer sheath to be "sucked" into the abdomen. The incision was extended to remove the sheath. Surgeon questions device problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021323 |
| MDR Report Key | 2163581 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-06-29 |
| Date of Event | 2011-06-28 |
| Date Added to Maude | 2011-07-21 |
| 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 | LAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH |
| Generic Name | SUPRAPUBIC CATH INTRODUCER |
| Product Code | KOB |
| Date Received | 2011-07-12 |
| Model Number | AC851 IRU-516-856 |
| Lot Number | 24369 |
| Device Expiration Date | 2014-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX - RUSCH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-12 |