MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for GLOVE SURGICAL PROTEXIS LATEX HYDROGEL 2D72LS75 manufactured by Cardinal Health (thailand) 222 Limited.
[139820741]
The complaint was forwarded to the manufacturing facility for investigation. The device history record of the complaint lot was reviewed. The lot was inspected and released in compliance with all requirements. The sample is enroute to the manufacturing facility. Once their investigation of it is completed, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139820742]
Cases were selective coronary angiograms (sca) with percutaneous coronary interventions (pci). During the pci the stickiness of the gloves would cause the coronary wire to dislodge from the lesion resulting in the physician needing to rewire the lesion. Per customer, no adverse effects to patients other than lengthened procedure times. No additional patient or event specifics provided by customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00294 |
| MDR Report Key | 8443702 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2018-10-17 |
| Date Added to Maude | 2019-03-22 |
| 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 LATEX HYDROGEL |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-03-22 |
| Catalog Number | 2D72LS75 |
| Lot Number | TS18100217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-22 |