MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-24 for BIOSORB 10/0 SUTURE manufactured by Alcon Laboratories, Inc.
[122723]
Nurse reports post-op suture breakage has been experienced in 6 pts at 3 different facilities following cataract procedures. Two of the pts required resuturing and the others were patched for several days. All the pts are fine with no other complications observed.
Patient Sequence No: 1, Text Type: D, B5
[15388441]
H. 6. : the returned sample was from a different lot than previously reported. Both of the lot numbers submitted were lots that were at the facility at the time. No record was made of the actual lot involved in the incident. Due to biohazard potential retained samples were checked for material defects and tested for usp tensile strength, rather than the returned samples. All findings met specs. This report was mailed in to fda on: 9/9/98.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-1998-00002 |
| MDR Report Key | 159277 |
| Report Source | 05,06 |
| Date Received | 1998-03-24 |
| Date of Report | 1998-02-23 |
| Date Mfgr Received | 1998-02-23 |
| Date Added to Maude | 1998-03-27 |
| 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 | BIOSORB 10/0 SUTURE |
| Generic Name | SURGICAL SUTURE |
| Product Code | HMN |
| Date Received | 1998-03-24 |
| Returned To Mfg | 1998-04-17 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 223392 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155135 |
| Manufacturer | ALCON LABORATORIES, INC |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-03-24 |