MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-11-30 for SURETY * 0-37867-212673 manufactured by The Kendall Company.
[203224]
Kendall healthcare received phone call reporting an adverse event that occurred with a surety belted xabs. Customer reported that found a piece of metal that had fallen out of the brief. This piece of metal allegedly was a fishhook. There were no pt injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522297-2000-00002 |
| MDR Report Key | 307624 |
| Report Source | 07 |
| Date Received | 2000-11-30 |
| Date of Report | 2000-11-09 |
| Date of Event | 2000-10-30 |
| Date Facility Aware | 2000-10-30 |
| Report Date | 2000-10-30 |
| Date Reported to Mfgr | 2000-10-30 |
| Date Mfgr Received | 2000-10-30 |
| Date Added to Maude | 2000-12-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MARK BROWN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616611 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURETY |
| Generic Name | ADULT BRIEF |
| Product Code | DPW |
| Date Received | 2000-11-30 |
| Model Number | * |
| Catalog Number | 0-37867-212673 |
| Lot Number | OA2103307:14 |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 297633 |
| Manufacturer | THE KENDALL COMPANY |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Baseline Brand Name | SURETY |
| Baseline Generic Name | ADULT BRIEF |
| Baseline Model No | * |
| Baseline Catalog No | 0-37867-212673 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-30 |