MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1997-06-12 for PAIR PAK SUTURE 8065-3054-01 manufactured by Alcon Laboratories, Inc..
[56258]
Surgeon reports suture was "easily breaking" and requiring more stitches than usual.
Patient Sequence No: 1, Text Type: D, B5
[7825561]
The nylon component of the suture, which was rpt'd to have broken, was not returned for evaluation, only the silk component was returned. Nylon suture from the same lot was retested and conformed to usp tensile strength specifications. No similar complaints have been received on this lot. This rpt was mailed in to fda on 8/21/97.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-1997-00001 |
| MDR Report Key | 98971 |
| Report Source | 01,05,06 |
| Date Received | 1997-06-12 |
| Date of Report | 1997-05-13 |
| Date Mfgr Received | 1997-05-13 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 1997-06-20 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAIR PAK SUTURE |
| Generic Name | * |
| Product Code | HMN |
| Date Received | 1997-06-12 |
| Returned To Mfg | 1997-05-21 |
| Model Number | NA |
| Catalog Number | 8065-3054-01 |
| Lot Number | M886240 |
| ID Number | PMA P880093 |
| Device Expiration Date | 2001-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 97541 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US |
| Baseline Brand Name | PAIR PAK SUTURE |
| Baseline Generic Name | * |
| Baseline Model No | NA |
| Baseline Catalog No | 8065-3054-01 |
| Baseline ID | PMA P880093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-12 |