MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-21 for VAPRO STANDARD CH 14 40 CM INTERMITTENT CATHETER 72144 manufactured by Hollister Incorporated.
[176231310]
Dhr review not possible because lot number is not known. Sample evaluation not possible because device not returned to hollister for testing. Trend analysis conducted and this is appears to be an isolated event. Patient's age and weight are not known so estimations used. Cause of blisters not determined. Reason for antibiotic use not provided.
Patient Sequence No: 1, Text Type: N, H10
[176231311]
The end user reported that he felt stinging when inserting the vapro intermittent urinary catheters. He stated they were giving him blisters. He said that his doctor said that he had blisters in his urethra possibly from the catheters. He is on antibiotics but he did not state why he was on antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616668-2020-00001 |
| MDR Report Key | 9612997 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2019-12-24 |
| Date Added to Maude | 2020-01-21 |
| 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. LINDA WISOWATY |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8476802170 |
| Manufacturer G1 | HOLLISTER ULC |
| Manufacturer Street | FOXFORD RD. REHINS |
| Manufacturer City | BALLINA, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAPRO STANDARD CH 14 40 CM INTERMITTENT CATHETER |
| Generic Name | VAPRO STANDARD CH 14 40 CM INTERMITTENT CATHETER |
| Product Code | GBM |
| Date Received | 2020-01-21 |
| Catalog Number | 72144 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE. 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-21 |