MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-19 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE MX833 manufactured by Ethicon, Inc..
[2976513]
It was reported that a patient underwent a spinal cord stimulator implant procedure on (b)(6) 2012 and suture was used to anchor the lead. The lead was migrating and the surgeon discovered that the non-absorbable suture had absorbed. There was no remnant of suture left at the anchor. A different type of suture was used in a follow-up surgery to correct the problem. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
[10181772]
(b)(4). Suture absorbed. Conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
[10260337]
Conclusion: one representative samples from the same lot number as the actual device were returned for evaluation. No actual returned used suture or explants were provided, so a complete examination was not possible. It could not be determined what suture was actually used in the procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-05458 |
| MDR Report Key | 2751232 |
| Report Source | 05,06 |
| Date Received | 2012-09-19 |
| Date of Report | 2012-08-31 |
| Date Mfgr Received | 2012-11-28 |
| Date Added to Maude | 2012-09-19 |
| 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 | MR. DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | ETHICON, INC. - JUAREZ |
| Manufacturer Street | AVE DE LAS TORRES #7125 COL SALVARCAR |
| Manufacturer City | JUAREZ 32580 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32580 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURE, NON-ABSORBABLE |
| Product Code | GAS |
| Date Received | 2012-09-19 |
| Returned To Mfg | 2012-09-13 |
| Model Number | NA |
| Catalog Number | MX833 |
| Lot Number | DBM197 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2012-09-19 |