MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-07 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[85272141]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[85272142]
It was reported by an attorney that the patient underwent a robotic-assisted supracervical hysterectomy, a robotic-assisted sacrocolpopexy, a sling procedure and a cystoscopy on (b)(6) 2013 and an unknown absorbable suture was used. After (b)(6) 2015, the patient developed symptoms of recurrent prolapse. The patient underwent another surgical procedure on (b)(6) 2016 for a recurrent stage iii cervical stump prolapse and failed abdominal sacrocolpopexy. The surgeon opines that the use of absorbable suture during the initial surgery caused the concomitant mesh to disengage and disintegrate. No additional information is provided at this time.
Patient Sequence No: 1, Text Type: D, B5
[106724475]
Additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2017-70227 |
| MDR Report Key | 6850083 |
| Date Received | 2017-09-07 |
| Date of Report | 2017-08-28 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 088760151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | GAK |
| Date Received | 2017-09-07 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-07 |