MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 1999-06-09 for ACUFEX, SURETAC II WITH SPIKES, 014567 manufactured by Smith & Nephew Inc. Endoscopy Division.
[17111158]
Device was reported to have broken during insertion. No pt injury was reported. No other information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1999-00044 |
| MDR Report Key | 227497 |
| Report Source | 01,05,06,07,08 |
| Date Received | 1999-06-09 |
| Date Mfgr Received | 1999-05-10 |
| Device Manufacturer Date | 1998-06-01 |
| Date Added to Maude | 1999-06-17 |
| 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 WITH SPIKES, |
| Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Product Code | MBJ |
| Date Received | 1999-06-09 |
| Model Number | NA |
| Catalog Number | 014567 |
| Lot Number | 501125 |
| ID Number | NA |
| Device Expiration Date | 2003-06-30 |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220602 |
| Manufacturer | SMITH & NEPHEW INC. ENDOSCOPY DIVISION |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Baseline Brand Name | ACUFEX, SURETAC II W/SPIKES STERILE |
| Baseline Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 014567 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-06-09 |