MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 1997-11-20 for ACUFEX TAG WEDGE 3.7MM, STERILE 013121 manufactured by Smith & Nephew, Inc..
[75143]
Contact stated tag wedge split upon insertion. Both pieces retrieved without injury or complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1997-00084 |
| MDR Report Key | 134823 |
| Report Source | 01,05,06,08 |
| Date Received | 1997-11-20 |
| Date of Event | 1997-10-21 |
| Date Facility Aware | 1997-10-21 |
| Date Mfgr Received | 1997-10-23 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1997-12-01 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX TAG WEDGE 3.7MM, STERILE |
| Generic Name | FIXATION IMPLANT |
| Product Code | MBJ |
| Date Received | 1997-11-20 |
| Model Number | NA |
| Catalog Number | 013121 |
| Lot Number | 003689 |
| ID Number | NA |
| Device Expiration Date | 2002-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 131746 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Baseline Brand Name | ACUFEX TAG 3.7MM WEDGE, BOX OF 1 STERILE |
| Baseline Generic Name | FIXATION IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 013121 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-11-20 |