MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-04-03 for MERSILENE POLYESTER FIBER SUTURE FRFB1728 manufactured by Ethicon, Inc.
[3413441]
It was reported that a patient underwent surgery for retinal detachment on an unknown date and suture was used. Approximately one month following the surgery, the patient experienced an inflammatory reaction to the stitches. Additional information requested.
Patient Sequence No: 1, Text Type: D, B5
[10646849]
(b)(4) - inflammation occurred. Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[18153715]
(b)(4): it was reported that the patient underwent the procedure on (b)(6) 2012. The first symptom of inflammatory conjunctiva was treated with corticosteroid. Without any efficiency, an infection has been declared. Cultures were performed. (b)(6) eye infection was diagnosed. A re-operation was performed on (b)(6) 2013 and the inflammatory mesh was removed. No defect of the suture was noticed during the second operation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-03420 |
| MDR Report Key | 3033541 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-04-03 |
| Date of Report | 2013-03-15 |
| Date Mfgr Received | 2013-04-23 |
| Date Added to Maude | 2013-04-03 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHY RICE |
| Manufacturer Street | 4545 CREEK ROAD MAIL LOCATION 120 |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON. SAS AUNEAU |
| Manufacturer Street | NEUILLY SUR SEINE, FRANCE |
| Manufacturer City | AUNEAU |
| Manufacturer Country | FR |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERSILENE POLYESTER FIBER SUTURE |
| Generic Name | SUTURE, NON ABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-04-03 |
| Model Number | NA |
| Catalog Number | FRFB1728 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-03 |