MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-04-11 for ACUFEX SURETAC II W/SPIKES, STERILE 014567 manufactured by Smith & Nephew Endoscopy, Inc..
[58647]
Pt reported to have frozen shoulder 6-8 weeks following shoulder surgery. A second arthroscopic procedure was performed to debride and manipulate shoulder. Biopsy revealed chronic inflammatory reaction. Pt has recovered well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1997-00028 |
| MDR Report Key | 84662 |
| Report Source | 05,07 |
| Date Received | 1997-04-11 |
| Date Mfgr Received | 1997-03-17 |
| Date Added to Maude | 1997-04-21 |
| 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 SURETAC II W/SPIKES, STERILE |
| Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Product Code | MBJ |
| Date Received | 1997-04-11 |
| Model Number | NA |
| Catalog Number | 014567 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 83914 |
| Manufacturer | SMITH & NEPHEW ENDOSCOPY, INC. |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-11 |