MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-20 for ACUFEX * 014567 manufactured by Acufex Mricrosurgical, Inc..
[38517]
The suretac would not hold the repair when placed in tissue. Promptly pulled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 58561 |
| MDR Report Key | 58561 |
| Date Received | 1996-12-20 |
| Date of Report | 1996-10-18 |
| Date of Event | 1996-10-16 |
| Date Facility Aware | 1996-10-16 |
| Report Date | 1996-11-18 |
| Date Reported to Mfgr | 1996-11-18 |
| Date Added to Maude | 1996-12-30 |
| 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 | ACUFEX |
| Generic Name | SURETAC II W/SPIKES (8MMX 16MM) |
| Product Code | MBJ |
| Date Received | 1996-12-20 |
| Model Number | * |
| Catalog Number | 014567 |
| Lot Number | 500700 |
| ID Number | * |
| Device Expiration Date | 1998-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 59013 |
| Manufacturer | ACUFEX MRICROSURGICAL, INC. |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-20 |