MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for GLOVE SURGICAL PROTEXIS PI MICRO 2D73PM65 manufactured by Cardinal Health (thailand) 222 Limited.
[139103469]
The device history record of the complaint lot was reviewed. The lot was inspected and released in compliance with all requirements. The customer had the sample but the manufacturing facility did not need it to be returned due to their identification of the problem. It appears that a new alternate source of polyisoprene had less tear resistance than a previous source for the same thickness control. We have resumed sourcing product from the previous supplier.
Patient Sequence No: 1, Text Type: N, H10
[139103470]
Physician complained of multiple glove tears during a laparoscopic tah bso - one glove tore in multiple pieces. Some pieces were retrieved from the abdomen and some were found on the floor of the or. The surgeon did order additional antibiotics. No additional updates available on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00287 |
| MDR Report Key | 8420674 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-09-30 |
| Date Added to Maude | 2019-03-14 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Street | 7/111 MOO 4 HIGHWAY #331, MABY |
| Manufacturer City | RAYONG 21140 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 21140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLOVE SURGICAL PROTEXIS PI MICRO |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-03-14 |
| Catalog Number | 2D73PM65 |
| Lot Number | TS18090309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Address | 7/111 MOO 4 HIGHWAY #331, MABY RAYONG 21140 TH 21140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-14 |