MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-13 for GUT CHR UD 27IN 2-0 S/A SH G123H manufactured by Ethicon Inc..
[185894252]
(b)(4). Attempts have been made to retrieve the device. 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
[185894253]
It was reported that a patient underwent a tonsillectomy procedure and suture was used. The suture was used on the soft palate and the needle broke off and fell into the patient. The pieces of the needle were found and retrieved by cutting away additional tissue and retrieved with a needle holder. The procedure was completed with a like device. The current condition of the patient is reported as good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00300 |
| MDR Report Key | 9580431 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-13 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUT CHR UD 27IN 2-0 S/A SH |
| Generic Name | SUTURE, ABSORBABLE, NATURAL |
| Product Code | GAL |
| Date Received | 2020-01-13 |
| Catalog Number | G123H |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |