MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-31 for CATGUT PLAIN 6 (10) 25M D2 F1144120 manufactured by B.braun Surgical Sa.
[173300118]
Pma/510k: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. K991223. No code available 3191 (veterinary case). If additional information becomes available a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[173300119]
It was reported that the thread broke after surgery. The reporter indicated that a veterinary case (cow) required a cesarean section. The uterus was sutured using the catgut. The peritoneum was sutured with vicryl and the skin was sutured with supramid white. Two days post-operative the cow developed complications: not eating, peritonitis and a hole in the uterus (which was noticed via rectal palpation). Measures taken by the surgeon: the catgut was replaced with vicryl. The cow was treated with antibiotics. Per the reporter the consequences of the incident: it is unknown if the animal can become pregnant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2019-00944 |
| MDR Report Key | 9536297 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-31 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2019-12-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SILVIA ORUS |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUBI, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B/ BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATGUT PLAIN 6 (10) 25M D2 |
| Generic Name | OTHER SUTURE |
| Product Code | GAL |
| Date Received | 2019-12-31 |
| Returned To Mfg | 2020-02-07 |
| Model Number | F1144120 |
| Catalog Number | F1144120 |
| Lot Number | 619155 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-31 |