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 2013-04-02 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE XNMEH7715N manufactured by Ethicon, Inc..
[3320814]
It was reported that a patient underwent a surgical procedure on an unknown date and suture was used. During the procedure, the knots came loose. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[10653697]
(b)(4). 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
[10691741]
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
| Report Number | 2210968-2013-03339 |
| MDR Report Key | 3031399 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-03-11 |
| Date Mfgr Received | 2013-04-15 |
| Date Added to Maude | 2013-04-02 |
| 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, 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, NONABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-04-02 |
| Model Number | NA |
| Catalog Number | XNMEH7715N |
| Lot Number | EM5460 |
| 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 | 2013-04-02 |